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Real world evidence: Perspectives from a European Society of Cardiology Cardiovascular Round Table with contribution from the European Medicines Agency.
Szymanski, Piotr; Weidinger, Franz; Lordereau-Richard, Isabelle; Himmelmann, Anders; Arca, Marcello; Chaves, Jose; Lee, Charles; Jonker, Carla; Kotecha, Dipak; O'Kelly, James; Plueschke, Kelly; Rys, Andrzej; Segec, Andrej; Wallentin, Lars; Veltrop, Rogier; James, Stefan.
Afiliación
  • Szymanski P; Clinical Cardiology Department, National Institute of Medicine MSWiA, Warsaw, Poland.
  • Weidinger F; Center for Postgraduate Medical Education, Warsaw, Poland.
  • Lordereau-Richard I; 2nd Medical Department with Cardiology and Intensive Care Medicine, Klinik Landstraße, Vienna, Austria.
  • Himmelmann A; General Medicine Europe, Amgen Europe, Rotkreutz ZG, Switzerland.
  • Arca M; Late-stage Development, Cardiovascular, Renal and Metabolism (CVRM), Clinical, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
  • Chaves J; Department of Translational and Precision Medicine, Sapienza University of Rome -Hospital Policlinico Umberto I, Rome, Italy.
  • Lee C; Global Medical Affairs, Internal Medicine Business Unit, Pfizer Biopharmaceuticals Group, Madrid, Spain.
  • Jonker C; Late Development Cardiovascular, Renal and Metabolism (CVRM) Regulatory Affairs, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
  • Kotecha D; Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, The Netherlands.
  • O'Kelly J; Institute of Cardiovascular Sciences, University of Birmingham, and University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
  • Plueschke K; Center for Observational Research (CfOR), Amgen, UK.
  • Rys A; Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, The Netherlands.
  • Segec A; Health Systems, Medical Products and Innovation, Directorate-General for Health and Food Safety (DG SANTE), European Commission, Brussels, Belgium.
  • Wallentin L; Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, The Netherlands.
  • Veltrop R; Uppsala Clinical Research Center, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
  • James S; Department of Biochemistry, CARIM, Maastricht University, Maastricht, The Netherlands.
Eur Heart J Qual Care Clin Outcomes ; 9(2): 109-118, 2023 02 28.
Article en En | MEDLINE | ID: mdl-36746430
Real world data (RWD) refers to healthcare information that is routinely collected in electronic healthcare records (EHR), hospital and pharmacy records, patient and disease registries, and health insurance databases. The collection and analysis of this vast amount of data is an important complement to that obtained from conventional randomised controlled trials (RCT). Real world data has been used for healthcare quality improvements, to conduct clinical trials, to support drug and device development, and to inform medical guidelines. The utility of RWD may be facilitated by common data models, which standardise format and content, and allow data from different health systems to be analysed together. The European Society of Cardiology (ESC) supports the use of RWD in collaboration with national cardiac societies, regulatory authorities, and industry to encourage continuous quality of care improvements at the hospital and country level, to conduct registry-based randomised clinical trials (R-RCT) and to facilitate safety surveillance of novel drugs and devices. The European Medicines Agency (EMA) is developing systems and processes to enable the use of RWD that can help in trial planning, defining clinical contexts, and enhancing outcome assessments. RWD can also contribute to the measurement of the impact of regulatory actions, such as contraindications or restriction of indications by looking at medicines use patterns over time across European Member States. A number of other initiatives from the European Commission and the EMA are underway to strengthen the EU's health security framework, and foster the collection and utilisation of RWD.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Cardiología Tipo de estudio: Clinical_trials / Guideline Límite: Humans Idioma: En Revista: Eur Heart J Qual Care Clin Outcomes Año: 2023 Tipo del documento: Article País de afiliación: Polonia Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Cardiología Tipo de estudio: Clinical_trials / Guideline Límite: Humans Idioma: En Revista: Eur Heart J Qual Care Clin Outcomes Año: 2023 Tipo del documento: Article País de afiliación: Polonia Pais de publicación: Reino Unido